Cardinal Health
Isolation Gown Universal Poly-Coated Spunbond Blue Over THE Head Thumbloop Latex Free Nonsterile Half Back
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Wonderful Nonwoven Technology Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 7 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Hubei Xinxin NON-Woven Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | QPC |
| Device type | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-05-10 |
| Record revised | 2024-11-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 10, case of 5 |
| Distribution end date | 2024-11-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4201PG | 10 | In distribution | |
| 4213PG | 10 | In distribution | |
| 4211PG | 10 | In distribution | |
| 4203PG | 10 | In distribution | |
| 42110PG | 6 | Withdrawn |
Same Product Code
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.